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by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
Cardiovascular Monitoring Devices
CFR Sub-Part
Diagnostic Devices
CFR Sub-Part
General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Miscellaneous
Miscellaneous
Monitoring Devices
CFR Sub-Part
Neurological Therapeutic Devices
CFR Sub-Part
Obstetrical and Gynecological Diagnostic Devices
CFR Sub-Part
Obstetrical and Gynecological Surgical Devices
CFR Sub-Part
Physical Medicine Therapeutic Devices
CFR Sub-Part
Prosthetic Devices
CFR Sub-Part
Surgical Devices
CFR Sub-Part
FAD
Stent, Ureteral
2
Product Code
EXX
Probe, Rectal, Non-Powered
1
Product Code
EYD
Stirrups
1
Product Code
EYH
Table, Cysto, Non-Electrical
1
Product Code
EYS
Ribdam
1
Product Code
EZO
Urethrotome
2
Product Code
EZP
Rod, Colostomy
2
Product Code
FAR
Unit, Electrosurgical
2
Product Code
FAS
Electrode, Electrosurgical, Active, Urological
2
Product Code
FBJ
Cord, Electric For Transurethral Surgical Instrument
2
Product Code
FBS
Sound, Metal, Interconnected
1
Product Code
FCH
Tray, Biopsy, Without Biopsy Instruments
1
Product Code
FCS
Light, Catheter, Fiberoptic, Glass, Ureteral
2
Product Code
FDB
Plate, Patient
2
Product Code
FDG
Retractor, Fiberoptic
1
Product Code
FDI
Snare, Flexible
2
Product Code
FDJ
Snare, Rigid Self-Opening
2
Product Code
FDL
Wristlet, Patient Return
2
Product Code
FEH
Electrode, Flexible Suction Coagulator
2
Product Code
FEO
Lithotriptor, Ultrasonic
2
Product Code
FFD
Evacuator, Bladder, Manually Operated
1
Product Code
FFE
System, Water Jet Catheter, Renal
2
Product Code
FFI
System, Alarm, Electrosurgical
2
Product Code
FFK
Lithotriptor, Electro-Hydraulic
2
Product Code
FFL
Dislodger, Stone, Basket, Ureteral, Metal
2
Product Code
FFN
Clamp, Non-Electrical
1
Product Code
FFO
Retractor, Self-Retaining
1
Product Code
FFQ
Speculum, Rectal
1
Product Code
FFR
Device, Locking, For Intestinal Clamp
1
Product Code
FGK
Tripsor, Stone, Bladder
2
Product Code
FGM
Probe And Director, Gastro-Urology
1
Product Code
FGN
Retractor, Non-Self-Retaining
1
Product Code
FGO
Dislodger, Stone, Flexible
2
Product Code
FGW
Clamp, Electrical
2
Product Code
FGX
Snare, Non-Electrical
1
Product Code
FHB
Hook, Gastro-Urology
1
Product Code
FHC
Adaptor To The Cord, For Transurethral Surgical Instrument
2
Product Code
FHF
System, Evacuator, Fluid
2
Product Code
FHH
Crusher, Spur, Colostomy
1
Product Code
FHI
Ring, Laparotomy
1
Product Code
FHK
Spreader, Bladder Neck
1
Product Code
FHL
Scoop
1
Product Code
FHN
Ligator, Hemorrhoidal
2
Product Code
FHQ
Holder, Needle, Gastroenterologic
1
Product Code
FHY
Jelly, Contact, For Transurethral Surgical Instrument
2
Product Code
FHZ
Desiccator, Transurethral
2
Product Code
FKK
Clamp, Line
1
Product Code
KGE
Forceps, Biopsy, Electric
2
Product Code
K
22
0053
Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI
2
Cleared 510(K)
K
21
0406
Bipolar Coagulation Foreceps
2
Cleared 510(K)
K
20
2438
Ensure Single-Use Coagulation Forceps
2
Cleared 510(K)
K
18
3428
Avulsion Forceps
2
Cleared 510(K)
K
18
0018
Disposable Hot Biopsy Forceps
2
Cleared 510(K)
K
18
0134
Ensizor Monopolar Endoscopic Scissors
2
Cleared 510(K)
K
17
1973
Captura® Disposable Hot Biopsy Forceps
2
Cleared 510(K)
K
17
1916
Single Use Hot Biopsy Forceps FD-231
2
Cleared 510(K)
K
17
1096
Fujifilm Diathermic Slitter (FlushKnife)
2
Cleared 510(K)
K
16
1186
Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)
2
Cleared 510(K)
K
16
0625
Disposable Hot Biopsy Forceps
2
Cleared 510(K)
K
15
1474
Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)
2
Cleared 510(K)
K
14
1794
ENDO-MARYLAND DISSECTOR
2
Cleared 510(K)
K
13
1991
ENDOCHOICE HOT BIOPSY FORCEPS
2
Cleared 510(K)
K
10
1657
RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 40
2
Cleared 510(K)
K
09
0796
MULTI-BITE HOT BIOPSY FORCEPS
2
Cleared 510(K)
K
09
0583
ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165
2
Cleared 510(K)
K
06
2517
ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES
2
Cleared 510(K)
K
02
2751
REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS
2
Cleared 510(K)
K
02
2243
HORIZONS REUSABLE HOT BIOPSY FORCEPS
2
Cleared 510(K)
K
02
1706
HORIZONS HOT BIOPSY FORCEPS
2
Cleared 510(K)
K
00
0086
WILSON-COOK REUSABLE HOT BIOPSY FORCEPS
2
Cleared 510(K)
K
99
2390
HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD
2
Cleared 510(K)
K
99
0231
WILTEK HOT BIOPSY FORCEPS
2
Cleared 510(K)
K
98
3811
UNIPOLAR OPTICAL BIOPSY FORCEPS
2
Cleared 510(K)
K
97
2505
RESUABLE HOT BIOPSY FORCEPS
2
Cleared 510(K)
K
97
0083
DYNABITE HOT GI BIOPSY FORCEPS
2
Cleared 510(K)
K
97
1204
LSVP INTERNATIONAL HOT BIOPSY FORCEPS
2
Cleared 510(K)
K
95
3355
GIP/MEID-GLOBE HOT BIOPSY FORCEPS
2
Cleared 510(K)
K
95
5052
OLYMPUS FD-1/2-1 HOT BIOPSY FORCEPS
2
Cleared 510(K)
K
95
1445
OLYMPUS FD-5 HOT BIOPSY FORCEPS
2
Cleared 510(K)
K
94
4765
KARL STORZ INSULATED BIOPSY FORCEPS, GRASPING/DISSECTING FORECPS, FLEXIBLE FORCEPS
2
Cleared 510(K)
K
94
3078
HOT BIOPSY FORCEPS
2
Cleared 510(K)
K
94
0911
BASICS ENDOSCOPY SYSTEM
2
Cleared 510(K)
K
93
2266
SYMBIOSIS DISPOS GASTRO BIOPSY FORCEPS W/REUSE HAN
2
Cleared 510(K)
K
93
2790
THERMAL OPTION
2
Cleared 510(K)
K
92
3470
DISPOSABLE HOT BIOPSY FORCEPS
2
Cleared 510(K)
K
92
5361
BIOPSY FORCEPS, ELECTRIC
2
Cleared 510(K)
K
91
0964
HOT BIOPSY FORCEPS
2
Cleared 510(K)
K
90
5088
HOT BIOPSY FORCEPS
2
Cleared 510(K)
K
90
4985
BIPOLAR BIOPSY FORCEPS
2
Cleared 510(K)
K
89
6537
PORGES HOT BIOPSY FORCEPS
2
Cleared 510(K)
KNS
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
2
Product Code
KOA
Surgical Instruments, G-U, Manual (And Accessories)
1
Product Code
KQS
Table, Cystometric, Non-Electric And Accessories
1
Product Code
KQT
Evacuator, Gastro-Urology
2
Product Code
LQC
Lithotriptor, Biliary Mechanical
2
Product Code
MMZ
Table, Cystometric, Electric
2
Product Code
MND
Ligator, Esophageal
2
Product Code
NLR
Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed
2
Product Code
NLT
Snare, Flexible, Reprocessed
2
Product Code
NLU
Forceps, Biopsy, Electric, Reprocessed
2
Product Code
NLV
Electrode, Flexible Suction Coagulator, Reprocessed
2
Product Code
NLW
Electrode, Electrosurgical, Active, Urological, Reprocessed
2
Product Code
NQT
Dislodger, Stone, Flexible, Ureteral, Reprocessed
2
Product Code
NQU
Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed
2
Product Code
NWI
Electrosurgical Electrode Kit
2
Product Code
OLH
Orchidometer
1
Product Code
ONJ
Dissolvable Gel For Preventing Ureteral Stone Migration
2
Product Code
OOW
Applicator For Rectal Suppository
1
Product Code
PKL
Hemostatic Metal Clip For The Gi Tract
2
Product Code
PLP
High Intensity Ultrasound System For Prostate Tissue Ablation
2
Product Code
PRU
Gastric Lavage Kit (Adult Or Pediatric Use)
2
Product Code
QGB
Ureteral Stent Accessories
1
Product Code
PVY
Vasovasostomy Set
1
Product Code
QAG
Endoscopic Electrosurgical Clip Cutting System
2
Product Code
LNK
Laser For Gastro-Urology Use
2
Product Code
MUK
Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue
2
Product Code
NEJ
System, Cryosurgical, Liquid Nitrogen, For Gastroenterology
2
Product Code
PZP
Fluid Jet Removal System
2
Product Code
Therapeutic Devices
CFR Sub-Part
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 26 May 2023 at 11:04 pm
GU
/
surgical-devices
/
KGE
/
K910964
View Source
HOT BIOPSY FORCEPS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K910964
510(k) Type
Traditional
Applicant
SYMBIOSIS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/2/1991
Days to Decision
57 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
Cardiovascular Monitoring Devices
Diagnostic Devices
General Hospital and Personal Use Miscellaneous Devices
Miscellaneous
Monitoring Devices
Neurological Therapeutic Devices
Obstetrical and Gynecological Diagnostic Devices
Obstetrical and Gynecological Surgical Devices
Physical Medicine Therapeutic Devices
Prosthetic Devices
Surgical Devices
FAD
Stent, Ureteral
EXX
Probe, Rectal, Non-Powered
EYD
Stirrups
EYH
Table, Cysto, Non-Electrical
EYS
Ribdam
EZO
Urethrotome
EZP
Rod, Colostomy
FAR
Unit, Electrosurgical
FAS
Electrode, Electrosurgical, Active, Urological
FBJ
Cord, Electric For Transurethral Surgical Instrument
FBS
Sound, Metal, Interconnected
FCH
Tray, Biopsy, Without Biopsy Instruments
FCS
Light, Catheter, Fiberoptic, Glass, Ureteral
FDB
Plate, Patient
FDG
Retractor, Fiberoptic
FDI
Snare, Flexible
FDJ
Snare, Rigid Self-Opening
FDL
Wristlet, Patient Return
FEH
Electrode, Flexible Suction Coagulator
FEO
Lithotriptor, Ultrasonic
FFD
Evacuator, Bladder, Manually Operated
FFE
System, Water Jet Catheter, Renal
FFI
System, Alarm, Electrosurgical
FFK
Lithotriptor, Electro-Hydraulic
FFL
Dislodger, Stone, Basket, Ureteral, Metal
FFN
Clamp, Non-Electrical
FFO
Retractor, Self-Retaining
FFQ
Speculum, Rectal
FFR
Device, Locking, For Intestinal Clamp
FGK
Tripsor, Stone, Bladder
FGM
Probe And Director, Gastro-Urology
FGN
Retractor, Non-Self-Retaining
FGO
Dislodger, Stone, Flexible
FGW
Clamp, Electrical
FGX
Snare, Non-Electrical
FHB
Hook, Gastro-Urology
FHC
Adaptor To The Cord, For Transurethral Surgical Instrument
FHF
System, Evacuator, Fluid
FHH
Crusher, Spur, Colostomy
FHI
Ring, Laparotomy
FHK
Spreader, Bladder Neck
FHL
Scoop
FHN
Ligator, Hemorrhoidal
FHQ
Holder, Needle, Gastroenterologic
FHY
Jelly, Contact, For Transurethral Surgical Instrument
FHZ
Desiccator, Transurethral
FKK
Clamp, Line
KGE
Forceps, Biopsy, Electric
K
22
0053
Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI
K
21
0406
Bipolar Coagulation Foreceps
K
20
2438
Ensure Single-Use Coagulation Forceps
K
18
3428
Avulsion Forceps
K
18
0018
Disposable Hot Biopsy Forceps
K
18
0134
Ensizor Monopolar Endoscopic Scissors
K
17
1973
Captura® Disposable Hot Biopsy Forceps
K
17
1916
Single Use Hot Biopsy Forceps FD-231
K
17
1096
Fujifilm Diathermic Slitter (FlushKnife)
K
16
1186
Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)
K
16
0625
Disposable Hot Biopsy Forceps
K
15
1474
Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)
K
14
1794
ENDO-MARYLAND DISSECTOR
K
13
1991
ENDOCHOICE HOT BIOPSY FORCEPS
K
10
1657
RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 40
K
09
0796
MULTI-BITE HOT BIOPSY FORCEPS
K
09
0583
ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165
K
06
2517
ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES
K
02
2751
REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS
K
02
2243
HORIZONS REUSABLE HOT BIOPSY FORCEPS
K
02
1706
HORIZONS HOT BIOPSY FORCEPS
K
00
0086
WILSON-COOK REUSABLE HOT BIOPSY FORCEPS
K
99
2390
HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD
K
99
0231
WILTEK HOT BIOPSY FORCEPS
K
98
3811
UNIPOLAR OPTICAL BIOPSY FORCEPS
K
97
2505
RESUABLE HOT BIOPSY FORCEPS
K
97
0083
DYNABITE HOT GI BIOPSY FORCEPS
K
97
1204
LSVP INTERNATIONAL HOT BIOPSY FORCEPS
K
95
3355
GIP/MEID-GLOBE HOT BIOPSY FORCEPS
K
95
5052
OLYMPUS FD-1/2-1 HOT BIOPSY FORCEPS
K
95
1445
OLYMPUS FD-5 HOT BIOPSY FORCEPS
K
94
4765
KARL STORZ INSULATED BIOPSY FORCEPS, GRASPING/DISSECTING FORECPS, FLEXIBLE FORCEPS
K
94
3078
HOT BIOPSY FORCEPS
K
94
0911
BASICS ENDOSCOPY SYSTEM
K
93
2266
SYMBIOSIS DISPOS GASTRO BIOPSY FORCEPS W/REUSE HAN
K
93
2790
THERMAL OPTION
K
92
3470
DISPOSABLE HOT BIOPSY FORCEPS
K
92
5361
BIOPSY FORCEPS, ELECTRIC
K
91
0964
HOT BIOPSY FORCEPS
K
90
5088
HOT BIOPSY FORCEPS
K
90
4985
BIPOLAR BIOPSY FORCEPS
K
89
6537
PORGES HOT BIOPSY FORCEPS
KNS
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
KOA
Surgical Instruments, G-U, Manual (And Accessories)
KQS
Table, Cystometric, Non-Electric And Accessories
KQT
Evacuator, Gastro-Urology
LQC
Lithotriptor, Biliary Mechanical
MMZ
Table, Cystometric, Electric
MND
Ligator, Esophageal
NLR
Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed
NLT
Snare, Flexible, Reprocessed
NLU
Forceps, Biopsy, Electric, Reprocessed
NLV
Electrode, Flexible Suction Coagulator, Reprocessed
NLW
Electrode, Electrosurgical, Active, Urological, Reprocessed
NQT
Dislodger, Stone, Flexible, Ureteral, Reprocessed
NQU
Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed
NWI
Electrosurgical Electrode Kit
OLH
Orchidometer
ONJ
Dissolvable Gel For Preventing Ureteral Stone Migration
OOW
Applicator For Rectal Suppository
PKL
Hemostatic Metal Clip For The Gi Tract
PLP
High Intensity Ultrasound System For Prostate Tissue Ablation
PRU
Gastric Lavage Kit (Adult Or Pediatric Use)
QGB
Ureteral Stent Accessories
PVY
Vasovasostomy Set
QAG
Endoscopic Electrosurgical Clip Cutting System
LNK
Laser For Gastro-Urology Use
MUK
Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue
NEJ
System, Cryosurgical, Liquid Nitrogen, For Gastroenterology
PZP
Fluid Jet Removal System
Therapeutic Devices
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
GU
/
surgical-devices
/
KGE
/
K910964
View Source
HOT BIOPSY FORCEPS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K910964
510(k) Type
Traditional
Applicant
SYMBIOSIS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/2/1991
Days to Decision
57 days